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GUIDANCE DOCUMENT

Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Guidance for Industry December 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2006-D-0362
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of claims made about a medical product in labeling. This guidance also does not address disease-specific issues. Guidance on clinical trial endpoints for specific diseases can be found on various FDA Web sites.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2006-D-0362.

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